Abstract:
:Laboratories contemplating either the addition of new molecular tests or modifying methods approved by the Food and Drug Administration for human papillomavirus testing should be aware of a variety of procedural, performance, and regulatory issues surrounding such activity. Diagnostic medical laboratory testing in the United States is regulated by the Centers for Medicare and Medicaid Services, an agency formerly known as the Health Care Finance Administration. The regulatory vehicle of the Centers for Medicare and Medicaid Services is manifested in the Clinical Laboratory Improvement Amendments (CLIA). The CLIA program has put into place specific regulations for laboratory quality control, which includes specific recommendations for method validation. Regulations that must be followed regarding personnel, quality control, quality assurance, method validation, and proficiency testing depend on the complexity category of the individual test. All molecular diagnostic tests, including those for human papillomavirus, are considered high complexity. The Centers for Medicare and Medicaid Services retains the authority to allow private, national accreditation organizations to "deem" that a laboratory is compliant with CLIA '88 requirements. Accreditation organizations, such as the Joint Commission for Accreditation of Hospitals, the Commission on Office Laboratory Accreditation, and the College of American Pathologists (CAP), as well as several state medical laboratory-accrediting agencies, possess the authority to deem laboratories as "CLIA-approved." The CAP, through its Laboratory Accreditation Program, has promoted standards for laboratory performance and method validation. In general, guidelines set forth in the CAP Laboratory Accreditation Program checklists specify that all clinical laboratory testing must essentially meet those requirements defined for high-complexity testing under CLIA '88, including test validation standards, reportable/reference ranges, performance criteria, and proficiency testing.
journal_name
Arch Pathol Lab Medjournal_title
Archives of pathology & laboratory medicineauthors
Seabrook JM,Hubbard RAdoi
10.1043/1543-2165(2003)127<978:AQRRAM>2.0.CO;2subject
Has Abstractpub_date
2003-08-01 00:00:00pages
978-83issue
8eissn
0003-9985issn
1543-2165journal_volume
127pub_type
杂志文章,评审abstract::The introduction of therapeutic digoxin antibodies in the treatment of digoxin toxicity has resulted in spurious results in the many assays of cardioglycoside in serum of patients receiving this therapy. An evaluation of currently used assay methods was incorporated into a pilot Ligand Assay Survey Program of the Coll...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:
更新日期:1989-11-01 00:00:00
abstract:BACKGROUND:The traditional normal range for prostate-specific antigen has been 0.0 to 4.0 ng/mL. Two different age-specific normal ranges have been proposed, one by Oesterling et al and the other generated by the Prostate Cancer Awareness Week experience. METHODS:We studied 213 consecutive cases of biopsy-proven prost...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:
更新日期:1998-04-01 00:00:00
abstract:CONTEXT:Platelet-derived microparticles (PDMPs) probably function in hemostasis, thrombosis, inflammation, and transfusion-related immunomodulation. OBJECTIVE:To compare PDMP levels of leukocyte-filtered and unfiltered whole blood during storage. DESIGN:Ten whole blood donations were collected and processed. Half of ...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:10.1043/1543-2165-134.5.771
更新日期:2010-05-01 00:00:00
abstract:CONTEXT:-Whole-slide imaging technology offers promise for rapid, Internet-based telepathology consultations between institutions. Before implementation, technical issues, pathologist adaptability, and morphologic pitfalls must be well characterized. OBJECTIVE:-To determine whether interpretation of whole-slide images...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:10.1043/1543-2165-133.12.1949
更新日期:2009-12-01 00:00:00
abstract:CONTEXT:-Evaluation of 12 or more lymph nodes (LNs) is currently used as a quality indicator for adequacy of pathologic examination of colon cancer resections. OBJECTIVE:-To evaluate the utility of a focused LN search in the immediate vicinity of the tumor and a "second look" protocol in improving LN staging in colon ...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:10.5858/arpa.2015-0401-OA
更新日期:2017-01-01 00:00:00
abstract::Phialemonium obovatum was found to be the cause of nosocomial osteomyelitis in a 41-year-old man after sustaining a nonpenetrating injury to his lumbar and cervical region. Histologic examination of fragments of disk and bone from L3-4 hemilaminectomy showed multiple fragments of fibrocartilage with focal necrosis, ch...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:
更新日期:1993-08-01 00:00:00
abstract::A causal role of coronary thrombosis in evolving myocardial infarction is now widely accepted. Patients recovering from an acute heart attack have a higher risk of dying, or suffering another infarction, than an age-matched non-coronary population. Thrombosis plays a major part in this additional mortality and morbidi...
journal_title:Archives of pathology & laboratory medicine
pub_type: 临床试验,杂志文章,随机对照试验,评审
doi:
更新日期:1993-01-01 00:00:00
abstract::A peroxidase--antiperoxidase technique for S100 protein has been applied to 122 breast lesions from 122 patients. These included 35 cases of fibrocystic disease, 16 cases of sclerosing adenosis, 24 cases of papilloma and papillomatosis, 43 intraduct carcinomas, and four intralobular carcinomas. In fibrocystic disease,...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:
更新日期:1987-01-01 00:00:00
abstract::Cytogenetic studies from the peripheral blood of a patient with malignant lymphoma and rheumatoid arthritis who was treated with intra-articular gold Au 198 revealed mosaicism with a normal female metaphase and a 43-chromosome metaphase. The abnormal cell line showed six missing normal chromosomes and three morphologi...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:
更新日期:1980-09-01 00:00:00
abstract::We describe unique features seen in a case of classic acoustic schwannoma. In the central portion of the tumor, abundant Rosenthal fibers and occasional eosinophilic granular bodies were present. Rosenthal fibers are homogeneous eosinophilic structures commonly seen in central nervous system lesions, such as pilocytic...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:
更新日期:1997-11-01 00:00:00
abstract::Concerns regarding significant levels of inappropriate medical services--as high as 20% or more--continue to influence discussions regarding medical care quality, utilization, and costs. The basis of these concerns are findings from a series of studies of the appropriateness of use of several medical and surgical serv...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:
更新日期:1990-11-01 00:00:00
abstract:CONTEXT:Accreditation Council for Graduate Medical Education guidelines require the evaluation of residents in 6 competencies. Pathology residents demonstrate medical knowledge, patient care, communication, and practice-based learning competencies in their attainment of competency in surgical pathology diagnosis. OBJE...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:10.1043/1543-2165(2006)130[188:LCEODC]2.0.CO;2
更新日期:2006-02-01 00:00:00
abstract:CONTEXT:There is no current standard among myopathologists for reporting muscle biopsy findings. The National Institute of Neurological Disorders and Stroke has recently launched a common data element (CDE) project to standardize neuromuscular data collected in clinical reports and to facilitate their use in research. ...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:10.5858/arpa.2014-0453-OA
更新日期:2016-01-01 00:00:00
abstract::We evaluated the utility of a monoclonal antibody that recognizes Pneumocystis carinii as a diagnostic tool in specimens of bronchoalveolar lavage fluid and sputum from patients in whom a diagnosis of P carinii pneumonia was being considered. In addition to routine processing for diagnosis by morphologic recognition o...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:
更新日期:1988-12-01 00:00:00
abstract:CONTEXT:Deletion of the short arm of chromosome 3 (3p deletion) is a cytogenetic abnormality generally associated with clear cell renal cell carcinoma, the most aggressive form of renal epithelial tumor. OBJECTIVE:To cytogenetically characterize 24 renal tumors in order to check the incidence and the type of 3p deleti...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:10.1043/1543-2165(2008)132[965:CSORET]2.0.CO;2
更新日期:2008-06-01 00:00:00
abstract:CONTEXT:- At our medical center, cytopathologists perform rapid on-site evaluation for specimen adequacy of fine-needle aspiration and touch imprint of needle core biopsy lung cancer samples. Two years ago the molecular diagnostics laboratory at our institution changed to next-generation sequencing using the Ion Torren...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:10.5858/arpa.2016-0096-OA
更新日期:2017-03-01 00:00:00
abstract:CONTEXT:-The data in College of American Pathologists cancer protocols have to be presented effectively to health care providers. There is no consensus on the format of those protocols, resulting in various designs among pathologists. Cancer protocols are independently created by site-specific experts, so there is inco...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:10.5858/arpa.2015-0237-OA
更新日期:2016-06-01 00:00:00
abstract:CONTEXT:Recent randomized controlled trials have shown a significant decrease in unsatisfactory rates for liquid-based cytology (LBC) compared with conventional Papanicolaou test (CP). The underlying causes and relevance of unsatisfactory results for LBC and CP have never been compared within the setting of a randomize...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:10.5858/arpa.2011-0113-OA
更新日期:2012-01-01 00:00:00
abstract:CONTEXT:Although most primary cancers of the lung carry a heavy mutational load and will potentially present many "nonself" antigens to the immune system, there are a wide range of possible mechanisms for tumors to avoid so-called immune surveillance. One such mechanism is the adoption of immune checkpoints to inhibit ...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章,评审
doi:10.5858/arpa.2015-0303-SA
更新日期:2016-03-01 00:00:00
abstract::Because massive pulmonary thromboembolism is a rarely described cause of sudden and unexpected death in the pediatric age group, a 50-year retrospective review of autopsy cases at the Hospital for Sick Children, Toronto, Canada, was conducted to determine the local incidence and clinicopathologic features of such pati...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:
更新日期:1990-02-01 00:00:00
abstract:OBJECTIVE:To investigate ras gene alteration in human gastric adenocarcinomas and its potential relationship to ras signal transduction mediators. DESIGN:Genomic DNA from 104 gastric tumors were analyzed by sequencing of polymerase chain reaction-amplified products for the presence of ras mutations. All the samples we...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:10.1043/0003-9985(2002)126<1096:RGMAEO>2.0.CO;2
更新日期:2002-09-01 00:00:00
abstract::This study was performed to evaluate the correlation between HER-2/neu gene expression and DNA ploidy patterns. Forty-five cases of breast-cancer were analyzed. Immunohistochemical staining of HER-2/neu protein on frozen sections was used to detect the HER-2/neu protein, and the Feulgen DNA staining method was used to...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:
更新日期:1990-02-01 00:00:00
abstract::Krukenberg tumor is an uncommon metastatic tumor of the ovary. This article provides an overview of the major pathologic manifestations of Krukenberg tumor, patient characteristics, clinical and laboratory features of the disease, prognostic factors, and current knowledge about its pathogenesis. Pathologists have to b...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章,评审
doi:10.1043/1543-2165(2006)130[1725:AILAKT]2.0.CO;2
更新日期:2006-11-01 00:00:00
abstract:CONTEXT:Hyalinizing spindle cell tumor with giant rosettes is a recently described biphasic neoplasm of soft tissues that shares mesenchymal and neuroendocrine features. Its morphologic structure is distinctive, with the presence of hyalinized paucicellular foci that are termed rosettes. The cells around the latter dis...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:10.1043/0003-9985(2000)124<1179:HSCTWG>2.0.CO;2
更新日期:2000-08-01 00:00:00
abstract:CONTEXT:Timely and accurate diagnosis of hematologic malignancies is crucial to appropriate clinical management. Acute leukemias are a diverse group of malignancies with a range of clinical presentations, prognoses, and preferred treatment protocols. Historical classification systems relied predominantly on morphologic...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章,评审
doi:10.1043/2010-0387-RAR.1
更新日期:2011-01-01 00:00:00
abstract:CONTEXT:Adenocarcinoma in situ of the cervix is a recently recognized interpretation in the Bethesda 2001 system. Although specific morphologic criteria have been published, recognizing this entity is still difficult. OBJECTIVE:To compare pathologists' ability to correctly identify and categorize adenocarcinoma in sit...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:10.1043/1543-2165(2004)128<153:DOAISO>2.0.CO;2
更新日期:2004-02-01 00:00:00
abstract::Renal solitary fibrous tumors (SFTs) have been reported infrequently. We report a 76-year-old man with a left renal mass that had previously been shown radiographically to be stable, but was now growing. Grossly, the mass measured 12 cm, was poorly circumscribed, and invaded beyond the renal capsule. Approximately 10%...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:10.1043/1543-2165(2006)130[857:MSFTOT]2.0.CO;2
更新日期:2006-06-01 00:00:00
abstract::Three patients with congenital partial absence of the right ventricular myocardium were studied. These cases are unique in that all three patients died suddenly and none had clinical evidence of cardiovascular disease. Two of the three patients were active in sports, and both died suddenly while playing basketball. At...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:
更新日期:1982-04-01 00:00:00
abstract:CONTEXT.—:The management of lobular neoplasia (LN) found on core biopsy is controversial and ranges from obligatory surgical excision to clinical/imaging observation. OBJECTIVE.—:To determine if in cases of core needle biopsy yielding LN, quantification of normal and diseased terminal ductal lobular units (TDLUs) can ...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:10.5858/arpa.2018-0232-OA
更新日期:2019-05-01 00:00:00
abstract::Striated muscle cells coexisting with neuroglial tissue were found in the leptomeninges of a 3-day-old neonate. An immunohistochemical study demonstrated the presence of myoglobin in the striated muscle cells, glial fibrillary acidic protein, and S-100 protein in the heterotopic glia, S-100 protein in the Schwann cell...
journal_title:Archives of pathology & laboratory medicine
pub_type: 杂志文章
doi:
更新日期:1984-07-01 00:00:00